Today’s Top Story
Study: Devices cleared under FDA 510(k) process see more recalls that those cleared via PMA.
A study published in the March 16 issue of The Journal of Bone & Joint Surgery finds that medical devices cleared by the U.S. Food and Drug Administration (FDA) 510(k) Premarket Notification process are 11.5 times more likely to be recalled than devices cleared under the more stringent Premarket Approval (PMA) process. The researchers reviewed information from the public FDA database on orthopaedic and non-orthopaedic devices that received market approval between 1992 and 2012. They found that over the study period the proportion of non-orthopaedic devices cleared via 510(k) decreased from 91 percent to 53 percent, and the proportion of orthopaedic devices decreased from 94 percent to 88 percent. Overall, the percentage of recalled devices was 17.8 percent for 510(k)-cleared devices and 1.6 percent for PMA-approved devices. When stratified on the basis of recall class, the odds ratios were 3.5 for class-I devices, 13.2 for class-II devices, and 8.5 for class-III devices. Read the abstract…
Other News
Study: Stemmed tibial components may offer little benefit to obese TKA patients.
Findings published online in the journal Clinical Orthopaedics and Related Research suggest little clinical improvement in patient-reported outcomes for obese patients who undergo total knee arthroplasty (TKA) and who are treated with stemmed tibial components. The authors conducted a randomized, controlled trial of 120 patients with a body mass index >30kg/m2. At 2-year follow-up, they found that patients treated with stemmed TKAs had higher functional outcomes, but note that “the differences were small and unlikely to be clinically important.” In addition, compared with patients with a stemmed TKA, patients with standard implants reported lower Knee Injury and Osteoarthritis Outcome Score (KOOS) pain subscores and lower KOOS symptom subscores. The authors found no significant difference between cohorts in likelihood of complication. Read the abstract…
Study: Opioid prescribing following common surgeries increased over 8-year period.
Data from a study published online in The Journal of the American Medical Association suggest an increasing trend in opioid prescribing for undergoing common surgical procedures. The research team analyzed insurance claims for 155,297 adults who underwent at least one of four common outpatient surgeries—carpal tunnel release, knee arthroscopy, laparoscopic cholecystectomy, or inguinal hernia repair. Patients were excluded if they had filled any opioid prescription in the 6 months prior to surgery. The research team found that, from 2004 through 2012, the proportion of patients filling prescriptions for any opioid and for hydrocodone/acetaminophen and oxycodone/acetaminophen increased over time for all surgical procedures. Overall, 80.0 percent filled a prescription for any opioid within 7 days of surgery, and 86.4 percent of those prescriptions were for hydrocodone/acetaminophen or oxycodone/acetaminophen. The proportion of patients filling a prescription for hydrocodone/acetaminophen or oxycodone/acetaminophen varied across surgical procedures from 59.7 percent (carpal tunnel release) to 75.5 percent (inguinal hernia repair). Read more…
Read the abstract…
In the most recent Morbidity and Mortality Weekly Report, the U.S. Centers for Disease Control and Prevention released an updated guideline for prescribing opioids for chronic pain. Read more…
Study: High school athletes who specialize may be at increased risk of overuse knee or hip injury.
A study published online in The American Journal of Sports Medicine suggests that highly specialized high school athletes may be more likely to report a history of overuse knee or hip injury. The authors surveyed 302 high school athletes who were classified as low specialization (n = 105), moderate specialization (n = 87), or high specialization (n = 110). They found that athletes in the high specialization cohort were more likely to report a history of overuse knee injuries (n = 18) compared with moderate (n = 8) or low specialization (n = 7) athletes. Overall, athletes who trained in one sport for more than 8 months out of the year were more likely to report a history of knee injuries, overuse knee injuries, and hip injuries. Read more…
Read the abstract…
Study: Use of oral contraceptives may modify risk of ACL injury in women.
According to a study published in the April issue of the journal Medicine & Science in Sports & Exercise, use of oral contraceptives may modify the risk of anterior cruciate ligament (ACL) injury in younger women. Researchers have proposed that high levels of the female hormone estrogen makes women more vulnerable to ACL injury by weakening this ligament, and that birth control pills can help maintain lower and more consistent levels of estrogen. The researchers conducted a case control study of 23,428 women aged 15 to 39 years. Among patients aged 15 to 19 years, they found that patients who underwent surgical ACL repair were 18 percent less likely to use oral contraceptives than matched controls. Across two older age groups, (25 to 29 years) and (30 to 34 years), patients who underwent surgical ACL repair were more likely to use oral contraceptives than controls. Read more…
Read the abstract…
Survey: Parents check—but may not trust—physician ratings.
A survey of parents conducted by C.S. Mott Children’s Hospital suggests that many lack trust in online physician ratings. The research team sent a survey to 1,407 nationally representative households and 54 percent responded. Overall, they found that 30 percent of respondents had looked at online physician ratings for themselves or a family member in the previous year. However, 69 percent stated that they believe at least some rating websites contain fake ratings, 64 percent believe that there were too few ratings to make a quality decision, and 54 percent opined that the physician may have influenced those who left the ratings. About 11 percent stated that they have posted a physician rating themselves. Read more…
Read the report (PDF)…
Resident Assembly Research Committee to host webinar on research during residency.
The AAOS Resident Assembly Research Committee will host a webinar, “Research During Residency: Executing Now with an Eye Towards Career Development,” on Thursday, March 31 at 7:30 p.m. CT. This webinar is the second of a two-part series, and will focus on tips for effectively completing research projects during residency. Topics to be discussed include effective time management, focusing research projects, collaborating with peers and attendings (as well as tips for effective remote collaboration), quantity versus quality, recruiting and training students as research assistants, grant applications, and how to get the most out of a research rotation or year. Register for the webinar…
Last call: CMS technical expert panel on quality measures of hospital visits after ASC procedures.
AAOS seeks to nominate members to a US. Centers for Medicare & Medicaid Services (CMS) Technical Expert Panel (TEP) to develop facility-level quality measures of hospital visits after procedures performed at ambulatory surgical centers (ASCs). The agency plans to use the measures to report on the quality of ASCs and prompt improvements in care for Medicare beneficiaries. Applicants for this position must be active fellows, candidate members, candidate members osteopathic, candidate member applicants for fellowship, or candidate member applicants for fellowship osteopathic. In addition, all applicants must provide the following: an online AAOS CAP application, a current curriculum vitae, a 100-word biosketch, a letter of interest highlighting their expertise in the subject area, and a nomination form. All supporting materials must be submitted to Kyle Shah by March 22, 2016 at 11:59 p.m. (CT). Request a copy of the nomination form and submit supporting materials to: shah@aaos.org
Learn more and submit your application…
